Comparing Daily vs Intermittent Regimen of ATT in HIV With Pulmonary Tuberculosis

Summary

Acquired Rifampicin Resistance has emerged as an important issue in the treatment of HIV-TB patients. It has not been a major problem in HIV-negative individuals treated for TB treated with standard intermittent regimens. The study would generate data on the efficacy of daily and thrice weekly regimen of ATT in pulmonary TB patients with HIV in the presence of highly active antiretroviral therapy (HAART). Not many trials have compared sputum conversion and adverse drug reaction between daily and intermittent regimens of ATT in HIV positive patients. This study provides a unique opportunity for comparison of daily and intermittent therapy for HIV patients with pulmonary TB looking into multiple dimensions of HIV-TB treatment namely efficacy, drug resistance, toxicity , drug interaction and immune reconstitution inflammatory syndrome. The primary outcome of the study is to compare the efficacy of three anti-TB regimens in a) reducing bacteriological failures and b) decreasing the emergence of Acquired Rifampicin Resistance (ARR). The secondary outcomes include unfavourable responses (clinical failures, deaths, relapses) as whole, treatment emergent adverse drug reactions, pharmacokinetic levels of ATT and incidence of immune reconstitution syndrome.

Timeline

Start

2009-09-14

Primary completion

2016-12-31

Completion

2018-06-30

Outcome

Met primary endpoint

paper a daily anti-TB regimen proved superior to a thrice-weekly regimen in terms of efficacy and emergence of rifampicin resistance. PMID 29507938 ↗

Publications

• Tiburcio R, Barreto-Duarte B, Naredren G, Queiroz ATL, Anbalagan S, Nayak K, Ravichandran N, Subramani R, Antonelli LRV, Satagopan K, Anbalagan K, Porter BO, Sher A, Swaminathan S, Sereti I, Andrade BB. Dynamics of T-Lymphocyte Activation Related to Paradoxical Tuberculosis-Associated Immune Reconstitution Inflammatory Syndrome in Persons With Advanced HIV. Front Immunol. 2021 Oct 7;12:757843. doi: 10.3389/fimmu.2021.757843. eCollection 2021.
• Gopalan N, Santhanakrishnan RK, Palaniappan AN, Menon PA, Lakshman S, Chandrasekaran P, Sivaramakrishnan GN, Reddy D, Kannabiran BP, Agiboth HKK, Krishnamoorthy V, Rathinam S, Chockalingam C, Manoharan T, Ayyamperumal M, Jayanthi N, Satagopan K, Narayanan R, Krishnaraja R, Sathiyavelu S, Kesavamurthy B, Suresh C, Selvachitiram M, Arasan G, Susaimuthu S, Rathinam P, Angamuthu P, Jayabal L, Murali L, Ramachandran R, Tripathy SP, Swaminathan S. Daily vs Intermittent Antituberculosis Therapy for Pulmonary Tuberculosis in Patients With HIV: A Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):485-493. doi: 10.1001/jamainternmed.2018.0141.

Drugs

Indications